RISPITAS 1 Tablets

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Risperidone

Available from:

Intas Pharmaceuticals Limited, INDIA

INN (International Name):

Risperidone

Pharmaceutical form:

Tablets

Manufactured by:

Intas Pharmaceuticals Limited , INDIA

Product summary:

Physical description: White to off white, round, flat faced beveled edged, uncoated tablet embossed with ''R2'' on one side and ''INTAS'' & bisecting line on other side of the tablet; Local technical representative: PHARMAJEN LIMITED (61840)

Authorization status:

Registered/Compliant

Authorization date:

2021-03-29

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
RISPITAS 1 (Risperidone Tablets USP 1 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains
Risperidone USP 1 mg
See List of Excipients in section 6.1.
3. PHARMACEUTICAL FORM
White to off white, round, flat faced bevelled edge uncoated tablet
embossed with R2 on
one side and INTAS & bisecting line on other side of the tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Risperidone
is
indicated
for
the
treatment
of
schizophrenia.
• Risperidone is indicated for the treatment of moderate to severe
manic episodes associated
with
bipolar
disorders.
•
Risperidone
is
indicated
for
the
short-term
treatment
(up
to
6
weeks)
of
persistent
aggression in patients with moderate to severe Alzheimer's dementia
unresponsive to non-
pharmacological
approaches
and
when
there
is
a
risk
of
harm
to
self
or
others.
• Risperidone is indicated for the short-term symptomatic treatment
(up to 6 weeks) of
persistent aggression in conduct disorder in children from the age of
5 years and adolescents
with
sub
average
intellectual
functioning
or
mental
retardation
diagnosed
according
to
DSM-IV criteria, in whom the severity of aggressive or other
disruptive behaviours require
pharmacologic treatment. Pharmacological treatment should be an
integral part of a more
comprehensive treatment programme, including psychosocial and
educational intervention.
It is recommended that risperidone be prescribed by a specialist in
child neurology and child
and adolescent psychiatry or physicians well familiar with the
treatment of conduct disorder
of children and adolescents
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Schizophrenia
_Adults _
Risperidone may be given once or twice daily.
Patient should start with 2 mg/day risperidone. The dosage may be
increased on the second
day
to
4
mg.
Subsequently,
the
dosage
can
be
maintained
unchanged,
or
further
individualised, if needed. Most patients will benefit from daily doses
between 4 and 6 mg.
In some